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NCT00112125 · ClinicalTrials.gov registry record · NA
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
A NA study, sponsored by Impulse Dynamics.
- Completed
- Registry status
- NA
- Development phase
- 428
- Enrollment target
NCT00112125: Completed NA study, sponsored by Impulse Dynamics.
NCT00112125 is a NA study that has completed, run by Impulse Dynamics. The registered enrollment target is 428 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00112125, a NA study, has completed, sponsored by Impulse Dynamics.
- COMPLETED
- Registry status
- NA
- Development phase
- 428 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
Primary Outcome
Number of participants with improvement in exercise tolerance at 24 weeks compared to baseline, as quantified by VO2 at ventilatory anerobic threshold (VAT) measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab. Note: An individual subject is considered a responder if VAT increases by ≥20% at 24 weeks compared to their respective baseline value.
Interventions
- DEVICE OPTIMIZER System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2005-02 |
| Est. Completion | 2019-03-19 |
| Phase | NA |
What the finished NCT00112125 record still lists
NCT00112125 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which OPTIMIZER System is the first listed.
NCT00112125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00112125 about?
NCT00112125 is a clinical study titled "Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5". The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
What is the current status of trial NCT00112125?
This trial is currently completed. It is a NA study. The enrollment target is 428 participants. The study started on 2005-02. Estimated completion is 2019-03-19.
What interventions are being tested in trial NCT00112125?
The interventions under investigation include: OPTIMIZER System (DEVICE).
Who is sponsoring clinical trial NCT00112125?
This trial is sponsored by Impulse Dynamics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00112125's enrollment target sits among peer trials
428 236th of 2000 higher than 1,765 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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